In mid-July, Abbott announced that it had received U.S. Food and Drug Administration approval for a next-generation version of its MitraClip® heart valve repair device used to repair a leaky mitral valve without open-heart surgery.
On July 31, the structural heart team at Ascension Via Christi Hospital became the first in the region to use the third generation of the transcatheter clip-based therapy that has been used to repair more than 65,000 patients' mitral valves over the last 10 years.
The newly approved next-generation MitraClip system provides cardiologists with advanced steering, navigation, and positioning capabilities for the clip, making it easier to use in difficult anatomies. The enhanced system is designed to allow for more precise placement during deployment, resulting in more predictable procedures, and additionally offers a second clip size with longer arms that expands the reach of the clip-based device. The additional clip size is designed to help doctors treat patients who have more complex anatomies when repairing the mitral valve.
“This is another first for Via Christi’s Structural Heart program and for Wichita as a whole,” says structural heart specialist Bassem Chehab, MD. “The enhanced and much-improved system is designed to help us treat patients who have more complex anatomies when repairing leaky mitral valves. It allows us to safely expand the reach of minimally invasive heart valve repair to a wider variety of patients.”
Dr. Chehab, along with cardio-thoracic surgeon Brett Grizzell, MD, performed the procedure using the device earlier this week. They, along with physician assistant Richard Allenbach, are part of the core team for Via Christi's Structural Heart program, which in the past four years has performed nearly 200 mitral valve repairs using Abbott's MitraClip devices and last month became the first in the nation to participate in Abbott’s U.S. pivotal trial of its Tendyne Transcatheter Mitral Valve Replacement system.
A leaking mitral valve, known as mitral regurgitation is a serious, progressive heart disease in which the flaps of the mitral valve do not close properly, allowing blood to flow backward into the heart. Incidence of mitral regurgitation increases with age, with nearly one in 10 people over the age of 75 having moderate to severe disease. Before MitraClip, people who were not eligible for the standard-of-care surgery to treat their MR could only manage their symptoms with medications that don't stop the progression of the disease. Left untreated, MR leads to a variety of life-altering symptoms and severe complications, and may ultimately lead to heart failure and death.
MitraClip treats people with degenerative mitral regurgitation and is a therapy that is delivered via a catheter to the heart through a blood vessel in the leg. MR patients are often not eligible for the standard-of-care surgery because of advanced age, frailty, multiple comorbidities or other complicating factors and the therapy offers a minimally invasive alternative. Treatment with MitraClip provides almost immediate symptom relief and patients are released from the hospital on average after two days.
Abbott recently began enrollment in the MitraClip EXPAND clinical study, a prospective study evaluating the safety and performance of its new system in a contemporary real-world setting. Via Christi is one the 50 centers across the United States and Europe that will be enrolling approximately 1,000 patients in the EXPAND study, for which interim results are expected later this year.